PCS Ferguson Quality Manual PCSF-01-01-001 rM Library/PCS/PCS-Ferguson-Quality-Manual.pdfPCS...

QUALITY MANUAL

PCSF-01-01-001

PCS Ferguson Quality Manual Revision

Page

1

Of

34 No. M

Date 2/2/2016

Date Printed: 6/10/2016 UNCONTROLLED PCS Ferguson Proprietary

Printed copies are valid only for the day they are printed, unless serialized and recorded in the Document Distribution Log on the PCS Ferguson QA SharePoint Site. Electronic copies are only valid if they are opened from the PCS

Ferguson QA SharePoint Controlled Document Library

PCS Ferguson

Quality Manual PCSF-01-01-001

Document revision history, change logs, and approvals are recorded

electronically, and available on the PCS Ferguson SharePoint site.

QUALITY MANUAL

PCSF-01-01-001


Page

2

Of

34 No. M

Date 2/2/2016




1 SCOPE, OBJECTIVE, AND PERMISSIBLE EXCLUSIONS .................................................................................................... 3

1.1 SCOPE ........................................................................................................................................................................... 3

1.2 OBJECTIVE ..................................................................................................................................................................... 3

1.3 PERMISSIBLE EXCLUSIONS ................................................................................................................................................. 3

2 NORMATIVE REFERENCES ........................................................................................................................................... 3

2.1 INTERNAL NORMATIVE REFERENCES .................................................................................................................................... 3

2.2 EXTERNAL NORMATIVE REFERENCES ................................................................................................................................... 3

3 TERMS AND DEFINITIONS ............................................................................................................................................ 4

3.1 ISO / API / QM CORRESPONDENCE ................................................................................................................................... 4

4 QUALITY MANAGEMENT SYSTEM ............................................................................................................................... 4

4.2 MANAGEMENT RESPONSIBILITY ......................................................................................................................................... 7

4.3 ORGANIZATIONAL CAPABILITY ............................................................................................................................................ 8

4.4 DOCUMENTATION ......................................................................................................................................................... 10

4.5 CONTROL OF RECORDS ................................................................................................................................................... 12

5 PRODUCT REALIZATION............................................................................................................................................. 12

5.1 CONTRACT REVIEW ........................................................................................................................................................ 13

5.2 PLANNING ................................................................................................................................................................... 14

5.3 RISK ASSESSMENT AND MANAGEMENT ............................................................................................................................. 14

5.4 DESIGN AND DEVELOPMENT ............................................................................................................................................ 15

5.5 CONTINGENCY PLANNING ............................................................................................................................................... 17

5.6 PURCHASING ................................................................................................................................................................ 18

5.7 PRODUCTION AND SERVICING .......................................................................................................................................... 20

5.8 CONTROL OF TESTING, MEASURING, AND MONITORING EQUIPMENT ...................................................................................... 24

5.9 PRODUCT RELEASE ........................................................................................................................................................ 26

5.10 CONTROL OF NONCONFORMING PRODUCT ........................................................................................................................ 26

5.11 MANAGEMENT OF CHANGE (MOC) .................................................................................................................................. 27

6 QMS MONITORING, MEASUREMENT, ASSESSMENT AND IMPROVEMENT ................................................................ 28

6.1 GENERAL ..................................................................................................................................................................... 28

6.2 MONITORING, MEASURING, AND IMPROVING .................................................................................................................... 28

6.3 ANALYSIS OF DATA ........................................................................................................................................................ 29

6.4 IMPROVEMENT ............................................................................................................................................................. 30

6.5 MANAGEMENT REVIEW .................................................................................................................................................. 31

7 ANNEX A: (INFORMATIVE) ......................................................................................................................................... 33

7.1 CROSS-REFERENCE BETWEEN API SPECIFICATION Q1, 9TH EDITION, PCS FERGUSON QUALITY MANUAL, AND ISO 9001:2015 ....... 33

8 ANNEX B: PCS FERGUSON INTERACTION OF PROCESSES (FLOWCHART) .................................................................... 34

QUALITY MANUAL

PCSF-01-01-001


Page

3

Of

34 No. M

Date 2/2/2016




1 Scope, Objective, and Permissible Exclusions

1.1 Scope This manual applies to all Operations and Manufacturing activities at PCS Ferguson facilities specifically

certified or applying for API Q1.

1.2 Objective The objective of the Quality Management System at PCS Ferguson, Frederick, Colorado is to implement

and maintain a management system that continually improves performance by addressing the needs of all

involved parties. The following principles have been identified to facilitate the achievement of this goal.

a) Customer Focus – We depend on our customers and understand their current and future needs.

We will continually strive to meet their requirements and exceed their expectations.

b) Leadership – PCS Ferguson management sets the purpose and objectives of the organization,

provides direction to the organization, and ensures the internal environment within the

organization allows and encourages employees to become fully committed and involved in

achieving those objectives.

c) Involvement of People – PCS Ferguson employees are totally involved at all levels and strive to

fully utilize their abilities to maximize the benefits to the organization and our customers.

d) Mutually Beneficial Supplier Relations – We are committed to supplier partnership which provides

mutual growth and financial benefits and creates value for our customers.

e) Process Approach – We have learned that the desired results are more efficiently achieved when

resources and activities are managed as a process.

f) Systems Approach – We understand that identifying, understanding and managing a system of

interrelated processes for a given objective contributes to the effectiveness and efficiency of the

business.

g) Continual Improvement – We believe that effective decisions are based on the logical or intuitive

analysis of data and information.

1.3 Permissible Exclusions a) No exclusions to API Q1, 9th Edition, are claimed by PCS Ferguson

b) No exclusions to ISO 9001:2015, are claimed by PCS Ferguson

2 Normative references 2.1 Internal Normative References

a) PCS Ferguson Employee Handbook

2.2 External Normative References a) ISO 9000, Quality Management Systems – Fundamentals and Vocabulary

b) ISO 9001:2015, Quality Management Systems – Requirements

QUALITY MANUAL

PCSF-01-01-001


Page

4

Of

34 No. M

Date 2/2/2016




c) API Specification Q1, 9th Edition - Specification for Quality Management System Requirements for

Manufacturing Organizations for the Petroleum and Natural Gas Industry.

3 Terms and definitions

For the purposes of this Quality Manual, the terms and definitions given in ISO 9000, ISO 9001:2015, and

API Specification Q1, 9th Edition, shall apply. When identical terms are defined in the normative references

and this manual, the following definitions shall apply.

a) Design Limit – Similar to Design Acceptance Criteria (DAC), defined limits placed on characteristics

of materials, products or services, established by the organization, customer, and/or applicable

specifications to achieve conformity to the product design.

b) Control Limit – Similar to Manufacturing Acceptance Criteria (MAC), defined limits placed on

characteristics of materials, products or services, established by the organization, customer,

and/or applicable specifications to achieve conformity to the manufacturing or servicing

requirements.

c) API – American Petroleum Institute

d) API Spec Q1 – API Specification Q1, 9th Edition

e) Dover Artificial Lift – PCS Ferguson’s parent company. Also known as DAL.

f) Dover – The parent company of Dover Artificial Lift and, by default, PCS Ferguson.

g) PCS Ferguson Top Management – The Managing Director and any or all of his direct reports

h) PCS Ferguson Management –All managers, directors, supervisors and leaders within the

organization.

3.1 ISO / API / QM Correspondence PCS Ferguson’s Quality Manual is written to correspond directly to the API Q1, 9th Edition Quality

Management System Specification. Correspondence to ISO 9001 may be found in Annex C of the API Q1

Specification.

4 Quality Management System 4.1.1 General Requirements

To ensure that products, services, and processes conform to specified requirements, PCS Ferguson has

established, documented, implemented, and shall maintain and continually improve our Quality

Management System in compliance with API Q1 9th Edition requirements.

The Quality Management System (QMS):

a) Determines the processes needed for our Quality Management System

b) Determines the sequence and interaction of these processes

c) Determines the criteria and methods needed to ensure the effective operation and control of

these processes

d) Ensures the availability of information necessary to support the operation and monitoring of

these processes

QUALITY MANUAL

PCSF-01-01-001


Page

5

Of

34 No. M

Date 2/2/2016




e) Identifies the methods to monitor, measure where applicable, and analyze these processes

f) Implements actions necessary to achieve planned results and continual improvement

g) Assigns responsibility for the development, planning, implementation, maintenance, and

continual improvement of the activities that affect quality.

Outside processes that affect quality conformity are controlled and identified within the QMS; in regards

to type and extent.

Strategic Planning outlines specific strategies by which to achieve objectives for quality. Through the

annual planning process, customer needs and market considerations are evaluated to develop

objectives and strategies. Plans are established by the organization and teams assigned to support

objectives and strategies. The Quality Management System and Policy is reviewed in annual

Management Reviews.

The following diagram (Ref Figure 4.1.0) depicts the elements and process of our Quality Management

System:

Figure 4.1.0 Source: ISO 9001:2015; Model of a Process-Based Quality Management System

QUALITY MANUAL

PCSF-01-01-001


Page

6

Of

34 No. M

Date 2/2/2016




4.1.2 Quality Policy

PCS Ferguson is dedicated to providing superior value, service, and quality to our customers by

understanding and meeting or exceeding their requirements, while maintaining compliance to all

industry and regulatory requirements.

PCS Ferguson is committed to the continual improvement of the Quality Management System. Quality

objectives are established, measured and communicated throughout the company.

In keeping this policy, PCS FERGUSON complies with API Specification Q1, 9th Edition, and ISO

9001:2015.

The Quality Policy will be defined, documented, approved and reviewed by Top Management during

Management Review to ensure:

a) It is appropriate and sufficiently serves the purpose of the current organization

b) It is communicated and understood throughout the organization

c) The organization identifies “Customer” as both External and Internal

d) The policy is effective and has measureable results

Department managers (Engineering, Operations/Manufacturing, Product Development, Finance, Sales

and Marketing, and Human Resources) are responsible for ensuring the understanding, implementation,

and maintenance of the PCS Ferguson Quality Policy within their respective organizations.

4.1.3 Quality Objectives

PCS Ferguson management ensures that quality objectives, including those needed to meet product

requirements, are established at relevant functions and levels within the organization. The quality

objectives are measurable and consistent with the quality policy.

Quality Objectives:

a) Customer Satisfaction

b) On-Time Delivery

c) Continual Improvement

d) API Spec Q1 Compliance

4.1.4 Planning

PCS Ferguson has defined and documented activities for meeting Quality requirements. Those activities

include any requirements necessary to maintain the quality and delivery of the product and maintaining

the integrity of the Quality Management System.

Quality Procedures shall describe the processes necessary to produce PCS Ferguson products, and the

degree of authority, applicable techniques, timely revision to processes and responsibility for each

function affecting quality activities.

QUALITY MANUAL

PCSF-01-01-001


Page

7

Of

34 No. M

Date 2/2/2016




PCS Ferguson management ensures that quality processes impacting the value of our products are

identified. Annual planning is conducted to maintain the link between strategic objectives and specific

quality goals.

4.1.5 Communications

PCS Ferguson Management ensures appropriate communication processes are established within the

organization and communication takes place regarding the effectiveness of the Quality Management

System.

4.1.5.1 Internal Communication PCS Ferguson Management ensures internal communication is executed through the use of production

travelers, tagging and marking procedures, inventory location, status boards, emails, scheduled and

unscheduled meetings, company newsletters, and reporting of Key Performance Indicators (KPI’s).

4.1.5.2 External Communication PCS Ferguson ensures external communication is executed through processes and procedures to establish

and assess customer satisfaction, contract review and supplier agreements and customer notifications.

Additionally, external communication is assured through sales presentations, company sales literature,

the company website, and direct and indirect communications with external customers.

4.2 Management Responsibility 4.2.1 General

PCS Ferguson Management is committed to the QMS and to continual improvement and preventive

actions by dedicating the resources for quality -related activities:

a) Communicate to the organization the importance of meeting Customer, Statutory, and Regulatory

requirements.

b) Establishing a Quality Policy, and quality objectives and key performance indicators (KPIs)

c) Conducting Management Reviews to compare results to established objectives and determining

subsequent actions for continual improvement and prevention (Ref. Section 6.5)

d) Ensuring the availability of resources

4.2.1.1 Customer Focus PCS Ferguson Management has established customer care and satisfaction as a core issue in the Quality

Policy.

a) Review of customer requirements in product development and order processing

b) Measuring customer satisfaction (Ref. Section 6.2.1)

QUALITY MANUAL

PCSF-01-01-001


Page

8

Of

34 No. M

Date 2/2/2016




4.2.2 Responsibility and Authority

The responsibility, authority, and interrelation of all personnel who manage, perform, or verify work

affecting product quality and delivery, has been defined and documented. All personnel have the freedom

to:

a) Initiate action to prevent the incidence of any product, process, or quality system related non-

conformance,

b) Identify and record any problems related to the product, process, or quality system,

c) Initiate, recommend, or provide solutions through designated channels,

d) Verify the implementation of solutions

4.2.3 Management Representative

PCS Ferguson Top Management has appointed the Management Representative for the Quality

Management System. The Management Representative has defined authority for:

a) Ensuring that PCS Ferguson Management identify and provide adequate resources ensuring the

processes needed for the Quality Management System are established, implemented and

maintained, at all times, in accordance with API Spec Q1 and ISO 9001:2015,

b) Reporting on the performance of the PCS Ferguson Quality Management System to PCS

Ferguson’s Top Management for review as a basis for improvement of the Quality System,

c) Ensuring initiation of action(s) to minimize likelihood of the occurrence of nonconformities, and

d) Promotion of awareness of Customer Requirements throughout the organization.

4.3 Organizational Capability 4.3.1 Provision of Resources

PCS Ferguson management and supervisory personnel identify and provide adequate resources,

applicable indoctrination and training of employees involved in the performance of development,

production, processing, assembly, inspection, and testing of PCS Ferguson product lines.

This includes resources needed to assess and improve the PCS Ferguson Quality Management System and

Customer Satisfaction.

4.3.2 Human Resources

Personnel performing work affecting conformity to product requirements are competent on the basis of

appropriate education, training, skills and experience.

4.3.2.1 General PCS Ferguson has established PCSF-01-02-018, Training, documenting the assessment and training needs

of PCS Ferguson employees.

4.3.2.2 Competence Training is provided according to determined need; to achieve the necessary competence where

applicable.

QUALITY MANUAL

PCSF-01-01-001


Page

9

Of

34 No. M

Date 2/2/2016




Required qualifications for specific tasks affecting conformity to product requirements are documented.

Where education and/or experience is required by job description: diplomas, certifications, transcripts,

and verified resumes are used to ensure the necessary requirements have been attained.

Appropriate records of training, education, skills, and experience are maintained in accordance with PCSF-

01-02-016, Control of Records.

4.3.2.3 Training and Awareness Employees are trained to perform their duties effectively and safely to achieve quality objectives and be

aware of the importance of their work to the Quality Management System.

Training requirements are identified and provided in accordance with documented procedures.

When an employee is accepted into a position, his/her previous training record will be reviewed. New

training requirements are identified and training is scheduled on a timely basis. Periodic re-training will

be conducted to meet changes and enhancements in relevant processes.

When training requirements for a position include training from a customer or a supplier for a given

product, process, or equipment, such training will be included in the training program, and the results

documented in the employee’s training record.

Records of education, qualifications, experience, and training are maintained in accordance with PCSF-01-

02-016, Control of Records.

The effectiveness of personnel training is critical to the performance of the QMS. Thus, the effectiveness

of employee training is continually evaluated. Methods of evaluation may include, but are not limited to:

a) Supervisor evaluation

b) Monitoring process performance

c) Corrective actions (i.e. from audits and customer returns)

d) Corrective/Preventive Action Requests

e) Management Review.

4.3.3 Work Environment

PCS Ferguson determines and manages the work environment needed to achieve conformity to product

requirements. This includes human, physical, and environmental factors.

PCS Ferguson determines, provides and maintains the infrastructure needed to achieve conformity to

product requirements:

a) Buildings, workspace and associated utilities

b) Process equipment (hardware and software) and production processes

c) Supporting services (information systems, maintenance)

QUALITY MANUAL

PCSF-01-01-001


Page

10

Of

34 No. M

Date 2/2/2016




4.4 Documentation 4.4.1 General

The PCS Ferguson Quality Management System includes:

a) The statements of Quality Policy (Ref Section 4.1.2) and Quality Objectives (Ref Section 4.1.3);

both contained in the Quality Manual.

b) The Quality Manual is a controlled document; published and revised by the Management

Representative to the Quality Management System. It includes:

i. The scope of the Quality Management System and any justification for exclusions (Ref.

Section 1)

ii. A description of the sequence and interaction of the processes of the Quality

Management System, refer to PCSF-01-01-002, PCS Ferguson Interaction of Processes

Flowchart, which may be found in Annex B of this document.

iii. Identification of processes that require validation (Ref. Section 5.7.1.5)

iv. Reference to documented procedures, work instructions, and forms; identified in the

Master Document List. (Refer to the figure 4.4.2.1, below).

c) The PCS Ferguson Quality Management System includes all procedures and processes to ensure

compliance to API Spec Q1 and ISO 9001:2015

d) The PCS Ferguson Quality Management System defines requirements for all documents and

records ensuring effective implementation and maintenance of the Quality Management System,

planning, operation and control of all processes within the Quality Management System, in

compliance with API Spec Q1 and ISO 9001:2015

e) The PCS Ferguson Quality Management System Identifies all legal and applicable requirements to

which the organization claims compliance

4.4.2 Procedures

The QMS described in the Quality Manual and procedures were created to meet API Spec Q1 requirements, ISO

9001:2015 requirements, regulatory requirements, for certifying agencies, and to ensure planning, operation,

and control of our processes are maintained.

a) Tier 1 – Quality Manual (QM) defines the scope and structure of the QMS.

b) Tier 2 – Quality Operating Procedures (QOP) identifies the activities and interrelationships that are

common to one or more department or organization.

c) Tier 3 – Work Instructions, Forms, Checklists, Records, etc.

QUALITY MANUAL

PCSF-01-01-001


Page

11

Of

34 No. M

Date 2/2/2016




Figure 4.4.2.1 Visual representation of the QMS document structure

All QMS Procedures are assigned and documented in the Master Document List and are implemented

and maintained for continued suitability. All Quality and QMS supporting Work Instructions, Checklists,

and Forms are assigned and documented in the Master Document List.

Department Procedures, Work Instructions, Checklists, Forms, specific to that department, may be

maintained and controlled by the department, in accordance with PCSF-01-02-005, Control of

Documents.

4.4.3 Control of Documents

PCS Ferguson has established PCSF-01-02-005, Control of Documents, to control all documents and data

that affect product, service, delivery, and process quality in accordance with the requirements of API

Spec Q1, ISO 9001:2015, and the Quality Management System.

The Master Document List details the current revision of Quality controlled documents.

Controlled documents are reviewed for adequacy and approved by the Controlling Department

Authority, respectively, the Management Representative to the Quality System, or designee prior to

release:

QUALITY MANUAL

PCSF-01-01-001


Page

12

Of

34 No. M

Date 2/2/2016




a) Engineering generates and controls drawings and bills of materials

b) Purchasing controls requisition forms and purchase orders

Changes to controlled documents are reviewed and re-approved by the same authority that approved

the original document, utilizing revision control. Revision changes will be detailed via the change

tracking feature in the document editing software.

The applicable issues of appropriate documents shall be available at all locations where operations

essential to the effective functioning of the Quality System are performed.

Illegible printed copies of controlled documents shall be removed from service and replaced, as they are

identified.

Obsolete documents shall be promptly removed from all points of issue or use, to prevent their

unintended or unauthorized use.

Where obsolete documents are authorized to be retained, they shall be identified as “OBSOLETE”.

Controlled documents are maintained within accordance with Section 4.5 of this Quality Manual.

4.4.4 Use of External Documents in Product Realization

Documents of external origin determined to be necessary are identified and distribution controlled by

the group utilizing the documents.

When API product or other external specification requirements, including addenda, errata, and updates,

are used in the design or manufacture of the product, the PCS Ferguson maintains a documented

procedure for the integration of these requirements into the product realization process and any other

affected processes.

4.5 Control of Records Records established to provide evidence of conformity to requirements and the effective operation of the

Quality Management System shall be controlled.

Records shall remain identifiable, retrievable, and legible; in accordance with the PCSF-01-02-016, Control

of Records. The procedure shall identify necessary controls and responsibilities needed for identification,

collection, storage, protection, retrieval, retention time and disposition of records.

Unless otherwise stated and where required by customer, legal, or other applicable requirements, Quality

records are to be retained for a period of five years from the date of origination, and shall be available to

PCS Ferguson personnel or customer representatives when required by contract.

5 Product Realization

QUALITY MANUAL

PCSF-01-01-001


Page

13

Of

34 No. M

Date 2/2/2016




5.1 Contract Review 5.1.1 General

PCS Ferguson has established PCSF-01-02-003, Contract Review, controlling the review of requirements

related to the provision of products and required servicing.

5.1.2 Determination of Requirements

PCSF-01-02-003, Contract Review documents the review and acceptance of customer orders and contracts

and for the coordination of these activities. PCS Ferguson considers a contract to be:

a) Written or verbal purchase orders accepted for standard products within normal forecast

quantities and delivery schedules.

b) A written or verbal purchase order accepted for non-standard products in accordance

with customer requirements within PCS Ferguson approved quantities and delivery

schedules.

Determinations made include:

a) Post-delivery activity requirements; determined before the order is accepted.

b) Requirements not stated by the customer but necessary for specified use, where known.

c) Applicable statutory and regulatory requirements related to the product

d) Any additional requirements considered necessary by PCS Ferguson

These requirements are defined in:

a) Accepted Customer Purchase Orders and other pertinent documents

b) PCS Ferguson Equipment Order Forms and associated documents

c) Accepted Change Orders / amendments

d) Written / verbal correspondence

e) Quotations for PCS Ferguson products and services

5.1.3 Review of Requirements

Representatives of PCS Ferguson follow established procedures for the review of:

a) Written or verbal quotes (proposals) prior to tender.

b) Written or verbal contracts during tender.

c) Written or verbal customer purchase orders after receipt.

Representatives of PCS Ferguson maintain contact with the customer representatives to ensure

differences are resolved prior to accepting customer orders.

Written or verbal orders shall be accepted only after a thorough review. The review ensures that:

a) The requirements of the contract or order are adequately defined and documented.

QUALITY MANUAL

PCSF-01-01-001


Page

14

Of

34 No. M

Date 2/2/2016




b) Any differences between the quote and the resulting contract or purchase order have

been resolved.

c) PCS Ferguson has the capability to meet the requirements of the contract or purchase

order.

Contract amendments shall be indicated in the contract or purchase documents in accordance with PCSF-

01-02-003, Contract Review, and the relevant people made aware of the change.

Documentation is retained in accordance with PCSF-01-02-016, Control of Records.

5.2 Planning Design input relating to product requirements shall be established and reviewed for completeness and

adequacy, and include:

a) Required resources and work environment

b) Product- and Customer- specified requirements

c) Legal and other applicable requirements

d) Contingencies based on risk assessment

e) Design and development requirements

f) Required verification, validation, monitoring, measurement, inspection and test

activities specific to the product and the criteria for product acceptance

g) Management of Change

h) Records needed to provide evidence the product realization processes meet

requirements

Each product design request shall be translated into a defined set of equipment requirements before

design begins.

Incomplete, vague or conflicting information shall be resolved prior to the release of the design.

Procedures shall be established for the resolution of ambiguous, incomplete or conflicting requirements.

Design requirements, methods, assumptions, analysis and calculations shall be documented. The

assignment of design responsibilities may be updated as required.

5.3 Risk Assessment and Management PCS Ferguson has established PCSF-01-02-025, Change Management, Risk and Contingency Planning, for

identifying and controlling risk associated with impact on product delivery and quality. This procedure

identifies the techniques and tools, and appropriate application for risk identification, assessment, and

mitigation.

Risk assessment associated with product delivery includes:

a) Facility and equipment availability and maintenance

b) Supplier performance and material availability and supply

Risk assessment associated with product quality includes:

QUALITY MANUAL

PCSF-01-01-001


Page

15

Of

34 No. M

Date 2/2/2016




c) Delivery of nonconforming product

d) Availability of competent personnel

Records of risk assessment and mitigation are maintained in accordance with the documented procedure

in accordance with PCSF-01-02-016, Control of Records.

5.4 Design and Development 5.4.1 Design and Development Planning

In order to ensure that specified requirements are met for a product, procedures are established and

documented to control and verify:

a) The plans, including plan updates, used for design development

b) The design and development stages

c) The resources, responsibilities, authorities, and their interfaces to ensure effective

communication

d) The review, verification, and validation activities necessary to complete each design and

development stage

e) The requirements for a final review of the design

Design and development responsibilities and authority are assigned to qualified personnel.

When design and development activities are performed at different locations within PCS Ferguson, the

procedure shall identify the controls required to ensure that the designs meet the requirements.

When design and development are outsourced, the PCS Ferguson ensures suppliers meet the

requirements of the design.

Planning output is to be updated, as appropriate, as the design and development progresses.

5.4.2 Design and Development Inputs

Design input, including technical and functional product requirements shall be established and reviewed

for completeness and adequacy, lack of conflict, and include:

a) Customer specified requirements

b) Requirements provided from external requirements, including API product specifications

c) Environmental and operational conditions

d) Methodology, assumptions, and formulae documentation

e) Historical performance and other information derived from previous similar designs.

f) Legal requirements

g) Results from risk assessments

Design requirements, methods, assumptions, analysis and calculations shall be documented and records

maintained in accordance with PCSF-01-02-016, Control of Records.

QUALITY MANUAL

PCSF-01-01-001


Page

16

Of

34 No. M

Date 2/2/2016




5.4.3 Design and Development Outputs

The design and development output shall be in a form suitable for verification against the design and

development input and shall be approved prior to release.

Outputs Shall:

a) Meet the design and development input requirements,

b) Provide appropriate information for purchasing, production, and where required,

servicing

c) Identify or reference Design Acceptance Criteria (DAC) and specification limits.

d) Identify or reference products and/or components deemed critical to the design

e) Include results of applicable calculations

f) Specify applicable regulatory criteria, and identify characteristics that are crucial to the

safe and proper function of the product

The design output shall be documented in accordance with established procedures in the form of

drawings, instructions, procedures and specifications.

5.4.4 Design and Development Review

Design output shall be reviewed at suitable stages, in accordance with planned arrangements:

a) To evaluate the suitability, adequacy, and effectiveness of the results of the design and

development stages to meet specified requirements

b) To identify any problems and propose necessary actions

Reviews are attended by all representatives of functions concerned with the design and development

stages being reviewed in accordance with PCS Ferguson’s Procedure PCSF-01-02-004, Design and

Development.

Records of the review results, any necessary actions, meeting notes, attendee lists are kept with the

appropriate design file; hardcopy or electronically in accordance with PCSF-01-02-016, Control of Records.

5.4.5 Design and Development Verification and Final Review

To ensure the outputs of the design and development meet the design input requirements, final review

and verification functions are planned, established, documented, and assigned to appropriate qualified

personnel.

Each new design shall be verified by one or more of the following:

a) Examination in a final design review conducted by Engineering and attended by

representatives of applicable departments.

b) Alternative calculations.

c) Performance of similar existing equipment, when applicable.

QUALITY MANUAL

PCSF-01-01-001


Page

17

Of

34 No. M

Date 2/2/2016




5.4.6 Design and Development Validation and Approval

Validation functions are planned to ensure that the resulting product is capable of meeting the specified

requirements, or intended use where known. Where possible, validation is done using the same or similar

resources, equipment, and procedures as used for the final product, and if practical, completed prior to

the delivery or implementation of the product. Records of validation results are maintained in the design

file; hardcopy or electronically.

Each new design shall be validated by one or more of the following:

a) Qualification testing of prototype equipment.

b) Alternative calculations.

c) Performance of similar existing equipment

The completed design shall be approved after validation. Approval must be by an assigned competent

individual(s) other than those who developed the design.

Records are maintained in accordance with PCSF-01-02-016, Control of Records.

5.4.7 Design and Development Changes

Design and development changes, including changes to design documents, require the same controls as

the original design and development.

All changes shall be:

a) Identified

b) Documented

c) Reviewed

d) Verified and validated when appropriate

e) Approved prior to implementation

The review will include evaluation of the effect of the changes (fit, function, performance) on the

component parts and product already delivered.

Records of the results of the review and any necessary changes are maintained in the appropriate design

file; hardcopy or electronically in accordance with PCSF-01-02-016, Control of Records.

5.5 Contingency Planning 5.5.1 General

In order to secure Quality and Delivery of PCS Ferguson products and services, contingency planning

requirements are documented in PCSF-01-02-025, Change Management, Risk and Contingency Planning,

to assess and address risk as part of design planning output.

5.5.2 Planning Output

Contingency planning output shall:

QUALITY MANUAL

PCSF-01-01-001


Page

18

Of

34 No. M

Date 2/2/2016




a) Identify significant risk scenarios to Quality and Delivery

b) Identify actions to mitigate significant risks

c) Assign responsibilities and authorities to actions

d) Establish internal and external communication controls

5.6 Purchasing 5.6.1 Purchasing Control

5.6.1.1 Procedure PCS Ferguson has implemented a procedure, PCSF-01-02-006, Purchasing Control to ensure purchased

products and activities conform to specified requirements. The procedure addresses the following

requirements:

a) Determination of the criticality of the activities or products, as applicable to conformance to

product and customer specifications

b) Initial evaluation and selection of suppliers based on their ability to supply activities or products

in accordance with PCS Ferguson’s requirements

c) Type and extent of control applied to the customer, based on the criticality of the product or

activity

d) Criteria, scope and methods for reassessment of suppliers

e) Maintaining a list of approved suppliers and the scope of approval

f) Type and extent of control to be applied to outsourced activities

5.6.1.2 Initial Supplier Evaluation for Critical Purchases When the purchased product, component, or activity is defined as critical, the criteria for the initial

evaluation of suppliers by PCS Ferguson shall be site-specific for each supplier.

The initial evaluation of suppliers of critical products, components, or activities shall include:

a) Verification the supplier’s Quality Management System (QMS) conforms to the requirements

specified by PCS Ferguson, and

b) Assess of the supplier to ensure its capability to meet PCS Ferguson’s purchasing requirements

by at least one of the following:

i. Performing an on-site evaluation of the relevant activities

ii. Performing first article inspection to ensure conformance to stated requirements

iii. When limited by proprietary, legal, or contractual arrangement, use of alternate,

documented methods to identify and verify how the supplied product conforms to PCS

Ferguson’s stated requirements.

5.6.1.3 Initial Supplier Evaluation for Noncritical Purchases For purchase of noncritical products, components, or activities which impact product realization or

which impact the final product, the criteria for evaluation of suppliers by PCS Ferguson may meet the

same requirements as those for critical purchases, as stated in 5.6.1.2, above, or one or more of the

following shall be satisfied:

QUALITY MANUAL

PCSF-01-01-001


Page

19

Of

34 No. M

Date 2/2/2016




a) Verification the supplier’s Quality Management System (QMS) conforms to the requirements

specified by PCS Ferguson, or

b) Assessment of the supplier to meet PCS Ferguson’s purchasing requirements, or

c) Assessment of the product upon delivery to PCS Ferguson, or supplied activity on completion

5.6.1.4 Supplier Reevaluation Reevaluation of all critical and noncritical suppliers shall meet the requirements of 5.6.1.3, above.

5.6.1.5 Records of Supplier Evaluation and Reevaluation Results of all evaluations and reevaluations, along with any necessary actions from those evaluations,

shall be recorded, and records maintained in accordance with PCSF-01-02-016, Control of Records.

5.6.1.6 Outsourcing For any outsourced activity that falls within the scope of PCS Ferguson’s Quality Management System,

PCS Ferguson shall ensure all applicable elements of the Quality Management System are satisfied.

PCS Ferguson maintains responsibility for product conformance to specified requirements, including

applicable API Product Specifications, for all outsourced activities associated with product realization.

Records of all outsourced activities, including supplier selection, evaluation and reevaluation, are

maintained in accordance with PCSF-01-02-016, Control of Records.

5.6.2 Purchasing Information

PCS Ferguson ensures the adequacy of specified purchasing information prior to communicating the

information to the supplier.

Purchasing information is documented to adequately describe the product or activity to be purchased,

including acceptance criteria for the product or activity, and, where appropriate, includes the following:

a) Requirements for approval of suppliers procedures, processes and equipment

b) Applicable version of specifications, drawings, process requirements, inspection instructions,

traceability, and other relevant technical data

c) Requirements for qualification of supplier’s personnel

d) Quality Management System requirements

5.6.3 Verification of Purchased Products or Activities

PCS Ferguson has established PCSF-01-02-010, Inspection and Testing, for verification and activities

ensuring purchased products or activities meet specified purchase requirements.

Where PCS Ferguson or a customer of PCS Ferguson intends to perform verification activities at a supplier’s

premises, PCS Ferguson shall state the intended verification arrangements and method of product release

in the purchasing information.

QUALITY MANUAL

PCSF-01-01-001


Page

20

Of

34 No. M

Date 2/2/2016




PCS Ferguson maintains records of verification activities that ensure purchased products and activities

conform to specified requirements, in accordance with the procedure of control of record PCSF-01-02-016,

Control of Records.

5.7 Production and Servicing 5.7.1 Control of Production and Servicing

5.7.1.1 Production PCS Ferguson has established PCSF-01-02-009, Process Control. describing controls associated with the

production of products. The procedure addresses the following:

a) The availability of information that describes the characteristics of the product;

b) Implementation of the product quality plan, when applicable (see 5.7.2);

c) Ensuring design requirements and related changes are satisfied, when applicable (see 5.4);

d) Availability and use of suitable production, testing, monitoring and measuring equipment;

e) Availability of work instructions, when applicable;

f) Process control documents (see 5.7.1.3);

g) Implementation of monitoring and measurement activities; and

h) Product release (see 5.9), including applicable delivery and post-delivery activities.

5.7.1.2 Servicing

The PCS Ferguson procedure PCSF-01-02-019, Servicing that describes controls associated with the

servicing (see 3.1.21) of products. The procedure shall address the following:

a) Review and implementation of the organization’s, customer-specific, product servicing, and

other servicing requirements;

b) The availability and use of suitable servicing, testing, monitoring, and measurement equipment;

c) The availability of work instructions, when applicable;

d) Ensuring identification and traceability requirements are maintained throughout the servicing

process;

e) Implementation of monitoring and measurement activities;

f) Process control documents (see 5.7.1.3); and

g) Requirements for release of the product that was serviced (see 5.9).

5.7.1.3 Process Control Documents Process controls are documented in engineering drawings, routings, travelers, checklists, process sheets, or

equivalent controls required by PCS Ferguson that include requirements for verifying conformance with

applicable product quality plans (see 5.7.2), API product specifications, customer requirements, and/or

other applicable product standards/ codes. The process control documents include or reference

instructions and acceptance criteria for processes, tests, inspections and required customer’s inspection

hold or witness points.

QUALITY MANUAL

PCSF-01-01-001


Page

21

Of

34 No. M

Date 2/2/2016




5.7.1.4 Product Realization Capability Documentation PCS Ferguson has established documentation that may include, but is not limited to, product realization

plans (see 5.2) and records of review/verification, validation, monitoring, measurement, inspection, and

test activities, including criteria for product acceptance that demonstrates the capability of PCS Ferguson to

satisfy specified product and/or servicing requirements.

NOTE: Product realization documentation is evidence of the capability of PCS Ferguson to

manufacture products or families of products and does not extend to every work order or

individual product manufactured.

5.7.1.5 Validation of Processes for Production and Servicing PCS Ferguson validates processes for production and servicing where the resulting output cannot be

verified by subsequent monitoring or measurement, and as a consequence, deficiencies become apparent

only after the product is in use or the servicing has been delivered. Validation demonstrates the ability of

these processes to achieve planned results. Where PCS Ferguson chooses to outsource a process that

requires validation, PCS Ferguson requires that the supplier conform to these requirements (see 5.6.1.6).

PCS Ferguson has established PCSF-01-02-022, Process Validation (Production and Servicing) to address

methods for review and approval of the processes including:

a) Required equipment;

b) Qualification of personnel;

c) Use of specific methods, including identified operating parameters;

d) Identification of acceptance criteria;

e) Requirements for records (see 4.5); and

f) Revalidation.

PCS Ferguson validates those processes identified by the applicable product specification as requiring

validation. If the processes are not identified, or there is no product specification involved, the processes

requiring validation include, as a minimum, non-destructive examination, welding, and heat treating, if

applicable to the product.

5.7.2 Product Quality Plans

PCS Ferguson maintains PCSF-01-02-021, PCS Ferguson Manufacturing Quality Plan, specifying the

processes of the quality management system (including the product realization processes) and the

resources to be applied to a product.

The plan, when combined with appropriate production planning documentation, as required by customer

contract, addresses each of the following as a minimum:

QUALITY MANUAL

PCSF-01-01-001


Page

22

Of

34 No. M

Date 2/2/2016




a) Description of the product to be manufactured;

b) Required processes and documentation, including required inspections, tests, and records, for

conformance with requirements;

c) Identification and reference to control of outsourced activities;

d) Identification of each procedure, specification, or other document referenced or used in each

activity; and

e) Identification of the required hold, witness, monitor and document review points.

Product quality plan and revisions are documented and approved by PCS Ferguson to ensure customer

requirements are met.

These product quality plan and any revisions are communicated to the customer.

NOTE 1: A product quality plan may be comprised of one or several different documents.

NOTE 2: A product quality plan is sometimes referred by other terms – such as quality plan

(QP), inspection and test plan (ITP), manufacturing process specification (MPS), process

control plan (PCP) and quality activity plan (QSP) – and often makes references to parts of the

quality manual or to production documents.

5.7.3 Identification and Traceability

PCS Ferguson has established PCSF-01-02-008, Product Identification and Traceability, for identification and

traceability of the product while the product is under control of PCS Ferguson; as required by PCS Ferguson,

the customer, and/or the applicable product specification throughout the product realization process,

including applicable delivery and post-delivery activities. PCSF-01-02-008, Product Identification and

Traceability includes requirements for maintenance or replacement of identification and/or traceability

marks.

Records of identification and traceability are maintained (see 4.5) in accordance with PCSF-01-02-016,

Control of Records.

5.7.4 Product Inspection / Test Status

PCS Ferguson has established PCSF-01-02-012, Inspection and Test Status, for the identification of product

inspection and/or test status throughout the product realization process that indicates the conformity or

nonconformity of product with respect to inspections and/or tests performed. PCS Ferguson ensures that

only product that meets requirements or that is authorized under concession (see 5.10.3) is released.

QUALITY MANUAL

PCSF-01-01-001


Page

23

Of

34 No. M

Date 2/2/2016




5.7.5 Customer-Supplied Property

PCS Ferguson has established PCSF-01-02-007: Control of Customer Supplied Product, for the identification,

verification, safeguarding, preservation, maintenance, and control of customer-supplier property, including

intellectual property and data, while under control of PCS Ferguson.

PCSF-01-02-007: Control of Customer Supplied Product includes requirements for reporting to the customer

any loss, damage, or unsuitability for use of customer-supplied property. Records for the control and

disposition of customer-supplied property are maintained (see 4.5) in accordance with PCSF-01-02-016,

Control of Records.

5.7.6 Preservation of Product

5.7.6.1 General PCS Ferguson has established PCSF-01-02-015: Handling, Storage, Packaging, Preservation, and Delivery,

which describes the methods used to preserve the product and constituent parts throughout product

realization and delivery to the intended destination in order to maintain conformity to requirements. As

applicable, preservation includes identification and traceability marks, transportation, handling, packaging,

and protection.

5.7.6.2 Storage and Assessment PCSF-01-02-015: Handling, Storage, Packaging, Preservation, and Delivery, identifies the requirements for

storage and assessment. PCS Ferguson uses designated storage areas or stock rooms to prevent damage or

deterioration of product, pending use or delivery.

In order to detect deterioration, the condition of product or constituent parts in stock will be assessed at

specified intervals identified by PCSF-01-02-015: Handling, Storage, Packaging, Preservation, and Delivery.

The interval is appropriate to the products or constituent parts being assessed.

Records of the results of assessments are maintained (see 4.5) in accordance with PCSF-01-02-016, Control

of Records.

5.7.7 Inspection and Testing

5.7.7.1 General PCS Ferguson has established PCSF-01-02-010: Inspection and Testing, for inspection and testing to verify

that product requirements have been met. This procedure includes requirements for in-process and final

inspection and testing. Records of required inspection and testing are maintained (see 4.5) in accordance

with PCSF-01-02-016, Control of Records.

5.7.7.2 In-Process Testing and Inspection PCS Ferguson inspects and tests the product at planned stages as required by the product quality plan (see

5.7.2), process control documents (see 5.7.1.3) and/or PCSF-01-02-010: Inspection and Testing. Evidence of

conformity with the acceptance criteria is maintained.

QUALITY MANUAL

PCSF-01-01-001


Page

24

Of

34 No. M

Date 2/2/2016




5.7.7.3 Final Inspection and Testing PCS Ferguson performs all final inspection and testing in accordance PCSF-01-02-010: Inspection and

Testing and, where required by contract, PCSF-01-02-021, PCS Ferguson Manufacturing Quality Plan, to

validate and document conformity of the finished product to the specified requirements.

Personnel other than those who performed or directly supervised the production of the product perform

final acceptance inspection at planned stages of the product realization process.

NOTE: Single-step manufacturing processes define in-process and Final Inspection & Testing

as one activity.

5.7.8 Preventive Maintenance

PCS Ferguson has established PCSF-01-02-023, Preventive Maintenance, for the establishment of preventive

maintenance for equipment used in product realization. The procedure identifies requirements for:

a) Type of equipment to be maintained;

b) Frequency; and

c) Responsible personnel.

Records of preventive maintenance are maintained (see 4.5) in accordance with PCSF-01-02-016, Control of

Records.

NOTE: Preventive maintenance can be based on risk, system reliability, usage history,

experience, industry recommended practices, relevant codes and standards, original

equipment manufacturer’s guidelines, or other applicable requirements.

5.8 Control of Testing, Measuring, and Monitoring Equipment PCS Ferguson determines the testing, monitoring, and measurement requirements and the associated

equipment needed to provide evidence of conformity to those requirements.

PCS Ferguson has established PCSF-01-02-011, Control of Test, Measurement, and Monitoring Equipment to

ensure that testing, measurement, and monitoring equipment is calibrated and maintained and that the

equipment is used in a manner that is consistent with monitoring and measurement requirements.

PCSF-01-02-011, Control of Test, Measurement, and Monitoring Equipment, includes requirements for the

specific equipment type that addresses:

a) Unique identifier;

QUALITY MANUAL

PCSF-01-01-001


Page

25

Of

34 No. M

Date 2/2/2016




b) Calibration status;

c) Equipment traceability to international or national measurement standards; where no such

standards exist, the basis used for calibration or verification is recorded (see 4.5) PCSF-01-02-016,

Control of Records;

d) Frequency of calibration, at specific intervals or prior to use;

e) Calibration or verification method, including adjustments and readjustments, as necessary;

f) Acceptance criteria;

g) Control of equipment identified as out-of-calibration in order to prevent unintended use; and

h) When the equipment is found to be out of calibration, an assessment of the validity of the previous

measurements and actions to be taken on the equipment and product, including maintaining

records and evidence of notification to the customer (see 4.1.5.2) if suspect product has been

shipped.

Testing, measuring, and monitoring equipment are to:

1) Be calibrated or verified, or both, against measurement standards;

NOTE 1: Verification against identified acceptance criteria is performed on nonadjustable

equipment.

2) Have the calibration status identifiable by the user for the activities being performed at all times;

3) Be safeguarded from adjustments that would invalidate the measurement result or the calibration

status;

4) Be protected from damage and deterioration during handling, maintenance, and storage; and

5) Be used under environmental conditions that are suitable for the calibrations, inspections,

measurements, and tests being carried out.

When used in the testing, monitoring, or measurement of specified requirements, the ability of computer

software to satisfy the intended application is confirmed prior to initial use and reconfirmed as necessary.

NOTE 2: Verification of the suitability of proprietary measurement equipment and evidence

of its conformity to the requirements of 5.8 may be limited by contract or licensing

agreement; however, the licensee is required to demonstrate the limitations imposed by the

contract in order to meet 5.8 c). 5.8 d), 5.8 e), and 5.8 f).

QUALITY MANUAL

PCSF-01-01-001


Page

26

Of

34 No. M

Date 2/2/2016




When the equipment provided from a source external to PCS Ferguson, including third-party, proprietary,

employee- and customer-owned equipment, PCS Ferguson verifies that the equipment is suitable and

provides evidence of conformity to requirements of this section.

PCS Ferguson maintains a registry of the required testing, measurement and monitoring equipment used to

determine product conformity to the requirements that includes a unique identification, specific to each

piece of equipment.

Records of results of calibration and verification are maintained (see 4.5) in accordance with PCSF-01-02-

016, Control of Records.

5.9 Product Release PCS Ferguson has established procedures to ensure release of product to the customer shall not proceed

until the planned arrangements (see 5.7) have been satisfactorily completed, unless otherwise approved by

a relevant authority and, where applicable, by the customer.

Records are maintained to enable identification of the individual releasing the product (see 4.5) in

accordance with PCSF-01-02-016, Control of Records.

5.10 Control of Nonconforming Product 5.10.1 General

PCS Ferguson has established PCSF-01-02-013, Control of Nonconforming Product, to identify the controls

and related responsibilities and authorities for addressing nonconforming product.

The PCSF-01-02-013, Control of Nonconforming Product addresses nonconforming product identified during

product realization and includes controls for:

a) Product identification to prevent unintended use or delivery;

b) Addressing the detected nonconformity (see 5.10.2);

c) Taking action to preclude its original intended use or delivery; and

d) Authorizing its use, release, or acceptance under concession by relevant authority and, where

applicable, by the customer (see 5.10.3).

The PCSF-01-02-013, Control of Nonconforming Product addresses nonconforming product identified after

delivery includes controls for:

1. Identifying, documenting, and reporting nonconformances or product failure identified after

delivery;

2. Ensuring the analyses of product nonconformance or failure, provided the product or documented

evidence supporting the conformity is available to facilitate the determination of the cause (see

6.4.2);

3. Taking action appropriate to the effects, or potential effects, of the nonconformance when

nonconforming product is detected after delivery.

QUALITY MANUAL

PCSF-01-01-001


Page

27

Of

34 No. M

Date 2/2/2016




5.10.2 Nonconforming Product

PCS Ferguson addresses nonconforming product by performing one or more of the following:

a) Repair or rework with subsequent inspection to meet specific requirements;

b) Re-grade for alternative applications;

c) Release under concession (see 5.10.3); and/or

d) Reject or scrap.

5.10.3 Release of Nonconforming Product Under Concession

PCS Ferguson has established PCSF-01-02-013, Control of Nonconforming Product, to include release of

product under concession. The evaluation and release under concession of nonconforming product that

does not satisfy manufacturing acceptance criteria (MAC) is permitted when PCS Ferguson relevant

authority and the customer (where applicable) have authorized the release provided that:

a) Products continue to satisfy the applicable DAC and/or customer criteria; or

b) The violated MAC are categorized as unnecessary to satisfy the applicable DAC and/or customer

criteria; or

c) The DAC are changed and the products satisfy the revised DAC and associated MAC requirements.

5.10.4 Customer Notification

PCS Ferguson notifies customers of product not conforming to DAC or contract requirements that have

been delivered.

PCS Ferguson maintains records of such notifications (see 4.5) in accordance with PCSF-01-02-016, Control

of Records.

5.10.5 Records

Records of the nature of nonconformities and any subsequent actions taken, including concessions

obtained, are maintained (see 4.5) in accordance with PCSF-01-02-016, Control of Records.

5.11 Management of Change (MoC) 5.11.1 General

PCS Ferguson has established PCSF-01-02-025, Change Management, Risk and Contingency Planning. PCS

Ferguson ensures that the integrity of the quality management system is maintained when changes to the

quality management system are planned and implemented. For MOC, PCS Ferguson identifies the potential

risks (see 5.3) associated with the change and any required approvals prior to the introduction of such

changes.

PCS Ferguson maintains records of MOC activities (see 4.5) in accordance with PCSF-01-02-016, Control of

Records.

QUALITY MANUAL

PCSF-01-01-001


Page

28

Of

34 No. M

Date 2/2/2016




5.11.2 MoC Implementation

PCS Ferguson uses the MOC process for any of the following that may negatively impact the quality of the

product:

a) Changes in PCS Ferguson organizational structure (see 4.2.2);

b) Changes in key or essential personnel (see 4.3.2);

c) Changes in critical supplier (see 5.6.1.1); and/or

d) Changes to the management system procedures, including changes resulting from corrective and

preventive actions (see 6.4).

5.11.3 MoC Notification

PCS Ferguson notifies relevant personnel, including the customer when required by contract, of the change

and residual or new risk due to changes that have either been initiated by PCS Ferguson or requested by

the customer.

6 QMS Monitoring, Measurement, Assessment and Improvement 6.1 General

PCS Ferguson plans and implements the monitoring, measurement, analysis, and improvement processes

needed to ensure conformity of the quality management system to the requirements of API Q1, 9th edition,

and to continually improve the effectiveness of the quality management system.

Quality management system monitoring, measurement, analysis, and improvement include determination

of applicable methods, including techniques for the analysis of data, and the extent of their use.

6.2 Monitoring, Measuring, and Improving 6.2.1 Customer Satisfaction

PCS Ferguson maintains PCSF-01-02-020, Analysis of Data, to measure customer satisfaction. PCSF-01-02-

020, Analysis of Data addresses the frequency of measurement; obtaining customer feedback, key

performance indicators (KPIs), and other information that PCS Ferguson uses to determine whether PCS

Ferguson has satisfied customers in meeting identified requirements. Records of the results of customer

satisfaction information are maintained (see 4.5), in accordance with PCSF-01-02-016, Control of Records.

6.2.2 Internal Audit

6.2.2.1 General PCS Ferguson has established PCSF-F01-02-017, Internal Quality Audits, to define responsibilities for

planning, conducting, and documenting internal audits. Audits verify that the quality management system

is effectively implemented and maintained and conforms to the requirements of this specification. The

planning of internal audits takes into consideration the results of previous audits and criticality of the

process being audited.

QUALITY MANUAL

PCSF-01-01-001


Page

29

Of

34 No. M

Date 2/2/2016




PCS Ferguson identifies the audit criteria, scope, frequency, and methods to ensure that all processes of the

quality management system claiming conformity to the requirements of this specification are audited at

least every 12 months.

Outsourced activities that impact the quality of the product and that are performed at PCS Ferguson

facilities are included as part of the internal audit of PCS Ferguson.

6.2.2.2 Performance of Internal Audit Audits are performed by competent personnel (see 4.3.2.2) independent of those who performed or

directly supervised the activity being audited to ensure objectivity and impartiality of the audit process.

Records of the audits provide objective evidence that the quality management system is implemented and

maintained (see 4.5), in accordance with PCSF-01-02-016, Control of Records.

All processes of the quality management system required to meet this specification are audited prior to

claiming conformance to the requirements of this specification.

NOTE: Product specification requirements may be embedded throughout the quality

management system processes and audited in conjunction with one or more quality

management system processes.

6.2.2.3 Audit Review and Closure PCS Ferguson identifies response times for addressing detected nonconformities. The management

responsible for the area being audited ensures that any necessary corrections and corrective actions follow

the requirements of 6.4.2. The results of internal audits and the status of corrective actions are reported in

the management review (see 6.5). Records of internal audits are maintained (see 4.5), in accordance with

PCSF-01-02-016, Control of Records.

6.2.3 Process Evaluation

PCS Ferguson applies suitable evaluation methods to demonstrate the ability of the quality management

system processes to achieve planned results, including conformity to the product requirements. When

planned results are not achieved, correction and corrective action are taken (see 6.4.2), as appropriate.

NOTE: Performance of internal audits and management reviews satisfy this requirement.

6.3 Analysis of Data PCS Ferguson has established PCSF-01-02-020, Analysis of Data, for the identification, collection, and

analysis of data to demonstrate the suitability and effectiveness of the quality management system. The

QUALITY MANUAL

PCSF-01-01-001


Page

30

Of

34 No. M

Date 2/2/2016




analysis includes data generated from monitoring and measurement, internal audits (see 6.2.2),

management reviews (see 6.5), and other relevant sources.

The data analysis output provides information relating to:

a) Customer satisfaction (see 6.2.1);

b) Conformity to product requirements;

c) Nonconformities and product failures identified after delivery or use, provided the product or

documented evidence is available to facilitate the determination of the cause (see 5.10);

d) Characteristics and trends of processes and products including opportunities for preventive action

(see 6.4.3);

e) Supplier performance (see 5.6); and

f) Quality objectives (see 4.1.3).

PCS Ferguson uses data to evaluate where continual improvement of the effectiveness of the quality

management system can be made.

6.4 Improvement 6.4.1 General

PCS Ferguson continually improves the effectiveness of the quality management system through the use of

the quality policy, quality objectives, audit results, analysis of data, corrective, preventive, and

improvement actions, and management review.

NOTE: See ISO 9000:2105 for definitions of correction, corrective action, and preventive action.

6.4.2 Corrective Action

PCS Ferguson has established PCSF-F01-QP-014, Corrective, Preventive, and Improvement Action to correct

nonconformities and to take corrective actions, both internally and within the supply chain, to eliminate the

causes of nonconformities in order to minimize the likelihood of its recurrence. Corrective actions are

appropriate to the effect(s) of the nonconformity encountered.

NOTE: Corrective action can apply to both quality management system processes and

nonconforming product trends.

PCSF-F01-QP-014, Corrective, Preventive, and Improvement Action identifies requirements for:

a) Reviewing a process nonconformity (including customer complaints);

b) Determining and implementing corrections;

QUALITY MANUAL

PCSF-01-01-001


Page

31

Of

34 No. M

Date 2/2/2016




c) Identifying the root cause of the nonconformity and evaluating the need for corrective actions;

d) Implementing corrective action to reduce the likelihood that a nonconformity recurs;

e) Identifying the timeframe and responsible person(s) for addressing corrections and corrective

action;

f) Verification of the effectiveness of the corrections and corrective action taken; and

g) MOC (see 5.11) when the corrective actions require new or changed controls within the quality

management system.

Records of the activities for control of a nonconforming process are maintained (see 4.5) in accordance

with PCSF-01-02-016, Control of Records. Records identify the activities performed to verify effectiveness of

the corrective actions taken.

6.4.3 Preventive Action

PCS Ferguson has established PCSF-F01-QP-014, Corrective, Preventive, and Improvement Action to

determine and implement preventive actions, both internally and within the supply chain, to eliminate the

causes of potential nonconformities in order to minimize the likelihood of their occurrence. Preventive

actions shall be appropriate to the effect(s) of the potential problem.

NOTE: Preventive action can apply to both quality management system processes and product

analysis.

PCSF-F01-QP-014, Corrective, Preventive, and Improvement Action identifies requirements for:

a) Identifying opportunities for improvements;

b) Identifying a potential nonconformity and its potential cause(s);

c) Evaluating the need for preventive action, including any immediate or short-term action required,

to prevent occurrence of a nonconformity;

d) Identifying the timeframe and responsible person(s) for implementing a preventive action;

e) Reviewing the effectiveness of the preventive action taken; and

f) MOC (see 5.11) when the preventive action require new or changed controls within the quality

management system.

Records of the activities for control of potential process nonconformities are maintained (see 4.5), in

accordance with PCSF-01-02-016, Control of Records.

6.5 Management Review 6.5.1 General

PCS Ferguson quality management system is reviewed at least every 12 months by PCS Ferguson's

management to evaluate the quality management system's continuing suitability, adequacy, and

effectiveness.

QUALITY MANUAL

PCSF-01-01-001


Page

32

Of

34 No. M

Date 2/2/2016




The review includes assessing opportunities for improvement and the need for changes to the quality

management system, including the quality policy and quality objectives.

6.5.2 Input Requirements

The input to management review includes, as a minimum:

a) Effectiveness of actions resulting from previous management reviews;

b) Results of audits (see 6.2.2);

c) Changes that could affect the quality management system, including changes to legal and other

applicable requirements (such as industry standards);

d) Analysis of customer satisfaction, including customer feedback (see 6.2.1);

e) Process performance {see 6.2.3 and 6.3 d);

f) Results of risk assessment (see 5.3);

g) Status of corrective and preventive actions (see 6.4.2 and 6.4.3);

h) Analysis of supplier performance (see 5.6);

i) Review of the analysis of product conformity, including nonconformities identified after delivery or

use (see 5.10); and recommendations for improvement.

6.5.3 Output Requirements

The output from the management review includes a summary assessment of the effectiveness of the

quality management system. The assessment includes any required changes (see 5.11) to the processes

and any decisions and actions, required resources, and improvement to products in meeting customer

requirements.

Top management reviews and approves the output of management reviews. Management reviews are

documented and records of these reviews are maintained (see 4.5), in accordance with PCSF-01-02-016,

Control of Records.

QUALITY MANUAL

PCSF-01-01-001


Page

33

Of

34 No. M

Date 2/2/2016




7 Annex A: (Informative) 7.1 Cross-Reference between API Specification Q1, 9th Edition, PCS Ferguson Quality Manual,

and ISO 9001:2015 PCS Ferguson’s Quality Manual is written to correspond directly to the API Q1, 9th Edition Quality

Management System Specification. Correspondence to ISO 9001 may be found in Annex C of the API Q1

Specification.

QUALITY MANUAL

PCSF-01-01-001


Page

34

Of

34 No. M

Date 2/2/2016




8 Annex B: PCS Ferguson Interaction of Processes (Flowchart) For easier viewing, printing, and reference, the flowchart is documented in PCSF-01-01-002, PCS Ferguson

Interaction of Processes Flowchart.

Figure 8.1.1: PCS Ferguson Interaction of Processes

PCS Ferguson Quality Manual PCSF-01-01-001 rM Library/PCS/PCS-Ferguson-Quality-Manual.pdfPCS...

Documents

Transcript of PCS Ferguson Quality Manual PCSF-01-01-001 rM Library/PCS/PCS-Ferguson-Quality-Manual.pdfPCS...